Thymalfasin added to standard care for adults with sepsis and immune dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This investigator-initiated, single-center trial will randomize 60 adults with sepsis and immune suppression to receive either standard sepsis care plus thymalfasin or standard care alone. The primary outcome is the change in monocyte HLA-DR expression from baseline to day 7, measured by flow cytometry. Participants and treating clinicians know the assigned treatment, while laboratory staff remain blinded to group assignment. The study aims to see if adding thymalfasin improves immune markers and potentially clinical recovery within the first week of ICU stay. Enrollment is within 48 hours of sepsis onset and follows Sepsis-3 criteria with an APACHE II score of 15–30 at ICU admission.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age older than 18 years, of any sex. Sepsis according to Sepsis-3 criteria, defined as documented or suspected infection with an increase in Sequential Organ Failure Assessment (SOFA) score of at least 2 points from baseline.

APACHE II score of 15 to 30, inclusive, at ICU admission. An immunosuppressed phenotype, defined by reduced monocyte HLA-DR expression meeting No more than 48 hours from sepsis onset to enrollment. Written informed consent provided by the participant or legally authorized representative.

Exclusion Criteria:

* Known allergy to thymalfasin or any of its excipients. A history of primary or acquired immunodeficiency, such as HIV infection or post-transplant immunosuppression.

Treatment with immunosuppressive agents or immunostimulants within 3 months before enrollment, including systemic corticosteroids at a prednisone-equivalent dose greater than 20 mg/day for at least 7 consecutive days, cyclosporine, tacrolimus, or azathioprine.

Active malignancy or ongoing anticancer treatment. Chronic liver disease classified as Child-Pugh class C, or end-stage renal disease requiring maintenance dialysis.

Pregnancy or breastfeeding. Expected survival of less than 48 hours at enrollment, such as irreversible brain death after cardiac arrest or terminal multiple organ failure.

Concurrent participation in another interventional clinical trial. Any other condition that, in the investigator's judgment, makes participation unsuitable.

Where it's running

• Zhongshan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Hongyu He — Fudan University
• Study coordinator: Hongyu He, PHD
• Email: he.hongyu@zs-hospital.sh.cn
• Phone: 13564155433

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Metabolic and Functional Study of γδ T Cells in Critically Ill Patients

  Researchers will look at how γδ T cells behave in severely ill patients, including those with sepsis, to see how their metabolism and function change.

  Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Outside of the US · NCT07680816

• Understanding blood changes after severe trauma

  This study looks at how severe injuries affect blood and bone marrow in trauma patients to see if it changes their immune response compared to patients having planned hip surgeries.

  Recruiting University of Florida · Gainesville, Florida · NCT05616130

• Ruta C and Vitamin C in Sepsis: Adding antioxidants to standard care

  This trial tests whether adding Ruta C (rutin plus vitamin C) or vitamin C alone to standard sepsis treatment helps adults in the ICU stay shorter and recover better.

  Recruiting Ain Shams University · Cairo, Cairo Governorate · NCT07922213

• Early detection of sepsis-related blood clotting problems in severe burn patients

  This study tests how well the JAAM-2 score can detect sepsis-induced coagulopathy early in adults with severe burns who develop sepsis in the ICU.

  Recruiting Center for Traumatology and Major Burns, Ben Arous · Tunis · NCT07914205

• Neutrophil EMR3 as a biomarker for sepsis in ICU patients

  Researchers will test whether measuring EMR3 on neutrophils helps diagnose sepsis, monitor progression, and predict outcomes in adults in Chinese ICUs.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang · NCT07896018

• Multicenter group study of sepsis and ARDS in China

  This study tests how sepsis and ARDS differ among adults across several Chinese hospitals and builds a biobank to understand why some patients do better or worse.

  Recruiting at 24 sites Shanghai Zhongshan Hospital · Xiamen, Fujian and 23 other locations · NCT07863908

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.